Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices
Strijbos, Ruben M.; Straatman, Louise V.; Calon, Tim G.A.; Johansson, Martin L.; de Bruijn, Arthur J.G.; van den Berge, Herbert; Wagenaar, Mariette; Eichhorn, Edwin; Janssen, Miranda; Jonhede, Sofia; van Tongeren, Joost; Holmberg, Marcus; Stokroos, Robert
(2021) Frontiers in Neurology, volume 12, pp. 1 - 14
(Article)
Abstract
Objective: Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months. Methods: In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for
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unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires. Results: Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%). Conclusion: The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02438618.
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Keywords: bone conduction device (BCD), hearing loss, minimally invasive ponto surgery, MIPS, soft tissue reactions, surgical outcomes, surgical technique, tissue preservation, Clinical Neurology, Neurology, Case Reports
ISSN: 1664-2295
Publisher: Frontiers Media S. A.
Note: Funding Information: The authors acknowledge the following people for their contribution to the investigation: Arpita Singh, Sara Svensson, Jan Leder (Oticon Medical AB), Marc van Hoof, Danielle Bollen, Afra Bruinen, Lucien Anteunis (MUMC), Manuela Joore (Maastricht University), and Joanne Schelhaas (Pento Audiologisch Centrum Twente). The authors acknowledge the valuable feedback on this work by Professor P. Thomsen (University of Gothenburg). Funding. This study was sponsored by Oticon Medical AB (Askim, Sweden). MLJ is supported by the research group of Professor P Thomsen (University of Gothenburg) and the resources provided by The Swedish Research Council (2018-02891), the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement (ALFGBG-725641), the IngaBritt and Arne Lundberg Foundation, the Adlerbertska Foundation, the Hjalmar Svensson Foundation, and the Area of Advance Materials of Chalmers/GU Biomaterials within the Strategic Research Area initiative launched by the Swedish government. Publisher Copyright: © Copyright © 2021 Strijbos, Straatman, Calon, Johansson, de Bruijn, van den Berge, Wagenaar, Eichhorn, Janssen, Jonhede, van Tongeren, Holmberg and Stokroos.
(Peer reviewed)
